Overview of chemotherapy- and lenalidomide-related toxicity according to M-CH status at MCL diagnosis and after ASCT
| Characteristic . | M-CH analyzed at diagnosis . | M-CH analyzed after ASCT . | ||||
|---|---|---|---|---|---|---|
| Patients who are M-CH− at diagnosis, n = 220∗ . | Patients who are M-CH+ at diagnosis, n = 34∗ . | P value† . | Patients who are M-CH− after ASCT, n = 167∗ . | Patients who are M-CH+ after ASCT, n = 24∗ . | P value‡ . | |
| Hematological toxicity after first R-CHOP | .2 | .2 | ||||
| G1-G2 | 35 (16%) | 3 (8.8%) | 21 (13%) | 6 (25%) | ||
| G3-G4 | 30 (14%) | 8 (24%) | 22 (13%) | 4 (17%) | ||
| No toxicity | 154 (70%) | 23 (68%) | 124 (74%) | 14 (58%) | ||
| NA | 1 | 0 | ||||
| Hematological toxicity after second R-CHOP | .4 | .7 | ||||
| G1-G2 | 35 (16%) | 3 (8.8%) | 21 (13%) | 4 (17%) | ||
| G3-G4 | 24 (11%) | 6 (18%) | 19 (11%) | 3 (12%) | ||
| No toxicity | 160 (73%) | 25 (74%) | 127 (76%) | 17 (71%) | ||
| NA | 1 | 0 | ||||
| Hematological toxicity after third R-CHOP | .6 | .3 | ||||
| G1-G2 | 40 (18%) | 4 (12%) | 26 (16%) | 5 (21%) | ||
| G3-G4 | 28 (13%) | 6 (18%) | 20 (12%) | 5 (21%) | ||
| No toxicity | 151 (69%) | 24 (71%) | 121 (72%) | 14 (58%) | ||
| NA | 1 | 0 | ||||
| Hematological toxicity after R-CTX | .2 | .013 | ||||
| G1-G2 | 14 (6.7%) | 0 (0%) | 10 (6.0%) | 2 (8.3%) | ||
| G3-G4 | 115 (55%) | 23 (70%) | 88 (53%) | 19 (79%) | ||
| No toxicity | 81 (39%) | 10 (30%) | 69 (41%) | 3 (12%) | ||
| NA | 10 | 1 | ||||
| Hematological recovery after ASCT | 136 (87%) | 19 (100%) | .13 | 117 (89%) | 15 (94%) | >.9 |
| NA | 64 | 15 | 35 | 8 | ||
| Days from ASCT to neutrophils ≥ 0.5 × 109/L | .11 | .5 | ||||
| Median (range) | 10 (6-70) | 11 (3-19) | 10 (7-70) | 11 (3-13) | ||
| NA | 46 | 9 | 17 | 5 | ||
| Days from ASCT to neutrophils ≥ 1.0 × 109/L | .11 | .7 | ||||
| Median (range) | 11 (4-132) | 12 (10-27) | 11 (4-132) | 11 (10-14) | ||
| NA | 56 | 11 | 25 | 8 | ||
| Days from ASCT to PLTS of ≥20 (×109/L) | .053 | .016 | ||||
| Median (range) | 13 (3-145) | 15 (6-54) | 13 (3-145) | 16 (7-29) | ||
| NA | 44 | 10 | 18 | 4 | ||
| Days from ASCT to PLTS of ≥50 (×109/L) | .6 | .3 | ||||
| Median (range) | 18 (6-726) | 20 (14-45) | 19 (6-726) | 21 (12-50) | ||
| NA | 67 | 15 | 35 | 9 | ||
| Randomized patients | 157 (71%) | 25 (74%) | .8 | 138 (83%) | 22 (92%) | .4 |
| Randomized to lenalidomide | 74 (34%) | 8 (24%) | .2 | 61 (37%) | 6 (25%) | .3 |
| Lenalidomide completed cycles, n | .5 | .4 | ||||
| Median (range) | 20 (0-24) | 17 (0-24) | 20 (0-24) | 16 (0-24) | ||
| NA | 136 | 24 | 96 | 16 | ||
| Lenalidomide dose reduction (%) | .3 | .3 | ||||
| Median (range) | 34 (0-100) | 57 (0-100) | 37 (0-100) | 26 (0-100) | ||
| NA | 136 | 24 | 96 | 16 | ||
| Skin secondary cancer | 2 (0.9%) | 0 (0%) | >.9 | 1 (0.6%) | 0 (0%) | >.9 |
| Secondary cancer (no skin) | 19 (8.6%) | 1 (2.9%) | .5 | 14 (8.4%) | 1 (4.2%) | .7 |
| Therapy-related hematological cancer | 7 (3.2%) | 0 (0%) | .6 | 6 (3.6%) | 1 (4.2%) | >.9 |
| Characteristic . | M-CH analyzed at diagnosis . | M-CH analyzed after ASCT . | ||||
|---|---|---|---|---|---|---|
| Patients who are M-CH− at diagnosis, n = 220∗ . | Patients who are M-CH+ at diagnosis, n = 34∗ . | P value† . | Patients who are M-CH− after ASCT, n = 167∗ . | Patients who are M-CH+ after ASCT, n = 24∗ . | P value‡ . | |
| Hematological toxicity after first R-CHOP | .2 | .2 | ||||
| G1-G2 | 35 (16%) | 3 (8.8%) | 21 (13%) | 6 (25%) | ||
| G3-G4 | 30 (14%) | 8 (24%) | 22 (13%) | 4 (17%) | ||
| No toxicity | 154 (70%) | 23 (68%) | 124 (74%) | 14 (58%) | ||
| NA | 1 | 0 | ||||
| Hematological toxicity after second R-CHOP | .4 | .7 | ||||
| G1-G2 | 35 (16%) | 3 (8.8%) | 21 (13%) | 4 (17%) | ||
| G3-G4 | 24 (11%) | 6 (18%) | 19 (11%) | 3 (12%) | ||
| No toxicity | 160 (73%) | 25 (74%) | 127 (76%) | 17 (71%) | ||
| NA | 1 | 0 | ||||
| Hematological toxicity after third R-CHOP | .6 | .3 | ||||
| G1-G2 | 40 (18%) | 4 (12%) | 26 (16%) | 5 (21%) | ||
| G3-G4 | 28 (13%) | 6 (18%) | 20 (12%) | 5 (21%) | ||
| No toxicity | 151 (69%) | 24 (71%) | 121 (72%) | 14 (58%) | ||
| NA | 1 | 0 | ||||
| Hematological toxicity after R-CTX | .2 | .013 | ||||
| G1-G2 | 14 (6.7%) | 0 (0%) | 10 (6.0%) | 2 (8.3%) | ||
| G3-G4 | 115 (55%) | 23 (70%) | 88 (53%) | 19 (79%) | ||
| No toxicity | 81 (39%) | 10 (30%) | 69 (41%) | 3 (12%) | ||
| NA | 10 | 1 | ||||
| Hematological recovery after ASCT | 136 (87%) | 19 (100%) | .13 | 117 (89%) | 15 (94%) | >.9 |
| NA | 64 | 15 | 35 | 8 | ||
| Days from ASCT to neutrophils ≥ 0.5 × 109/L | .11 | .5 | ||||
| Median (range) | 10 (6-70) | 11 (3-19) | 10 (7-70) | 11 (3-13) | ||
| NA | 46 | 9 | 17 | 5 | ||
| Days from ASCT to neutrophils ≥ 1.0 × 109/L | .11 | .7 | ||||
| Median (range) | 11 (4-132) | 12 (10-27) | 11 (4-132) | 11 (10-14) | ||
| NA | 56 | 11 | 25 | 8 | ||
| Days from ASCT to PLTS of ≥20 (×109/L) | .053 | .016 | ||||
| Median (range) | 13 (3-145) | 15 (6-54) | 13 (3-145) | 16 (7-29) | ||
| NA | 44 | 10 | 18 | 4 | ||
| Days from ASCT to PLTS of ≥50 (×109/L) | .6 | .3 | ||||
| Median (range) | 18 (6-726) | 20 (14-45) | 19 (6-726) | 21 (12-50) | ||
| NA | 67 | 15 | 35 | 9 | ||
| Randomized patients | 157 (71%) | 25 (74%) | .8 | 138 (83%) | 22 (92%) | .4 |
| Randomized to lenalidomide | 74 (34%) | 8 (24%) | .2 | 61 (37%) | 6 (25%) | .3 |
| Lenalidomide completed cycles, n | .5 | .4 | ||||
| Median (range) | 20 (0-24) | 17 (0-24) | 20 (0-24) | 16 (0-24) | ||
| NA | 136 | 24 | 96 | 16 | ||
| Lenalidomide dose reduction (%) | .3 | .3 | ||||
| Median (range) | 34 (0-100) | 57 (0-100) | 37 (0-100) | 26 (0-100) | ||
| NA | 136 | 24 | 96 | 16 | ||
| Skin secondary cancer | 2 (0.9%) | 0 (0%) | >.9 | 1 (0.6%) | 0 (0%) | >.9 |
| Secondary cancer (no skin) | 19 (8.6%) | 1 (2.9%) | .5 | 14 (8.4%) | 1 (4.2%) | .7 |
| Therapy-related hematological cancer | 7 (3.2%) | 0 (0%) | .6 | 6 (3.6%) | 1 (4.2%) | >.9 |
Boldface values indicate statistically significant P values (P < .05). G1-G2, grade 1 or grade 2 toxicity; G3-G4, grade 3 or grade 4 toxicity; NA, data not available; PLTS, platelets; R-CTX, rituximab in combination with cyclophosphamide.
n (%).
Pearson χ2 test; Fisher exact test; Wilcoxon rank-sum test.
Fishers exact test; Pearson χ2 test; Wilcoxon rank-sum test.